281 results match your criteria: "George Washington University Biostatistics Center[Affiliation]"

Objective: GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort.

Research Design And Methods: Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA 6.

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Objective: We examined the relationship between habitual daily physical activity and measures of glucose tolerance, insulin sensitivity, and β-cell responses in adults with impaired glucose tolerance (IGT) or drug-naive, recently diagnosed type 2 diabetes.

Research Design And Methods: Participants included 230 adults (mean ± SD age 54.5 ± 8.

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Objective: In the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, metformin plus rosiglitazone (M + R) maintained glycemic control better than metformin alone (M) or metformin plus lifestyle (M + L) in youth with type 2 diabetes (T2D). We hypothesized that changes in visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) would explain the differential treatment effects on glycemia.

Research Design And Methods: In 626 youth ages 11-17 years with T2D duration <2 years, VAT and SAT were estimated by DXA at baseline and at 6 and 24 months.

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Background: Antenatal exposure to intra-uterine inflammation results in precocious Haptoglobin (Hp) expression (switch-on status). We investigated the relationships between foetal Hp expression at birth with newborn and childhood outcomes.

Methods: We evaluated cord blood samples from 921 newborns of women at imminent risk for preterm delivery randomised to either placebo (n = 471, birth gestational age (GA) median [min-max]: 31 [24-41] weeks) or magnesium sulphate (n = 450, GA 31 [24-42] weeks]).

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Objective: Sleep disturbances and circadian misalignment (social jet lag, late chronotype, or shift work) have been associated with worse glycemic control in type 2 diabetes (T2D). Whether these findings apply to adults with prediabetes is yet unexplored. We hypothesized that self-reported short sleep, poor sleep quality, and/or circadian misalignment are associated with higher glycemia, BMI, and blood pressure (BP) in adults with prediabetes or recently diagnosed, untreated T2D.

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Background: Identifying reliable predictors of long-term weight loss (LTWL) could lead to improved weight management.

Objective: To identify some predictors of LTWL.

Design: The DPP (Diabetes Prevention Program) was a randomized controlled trial that compared weight loss with metformin, intensive lifestyle intervention (ILS), or placebo.

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Objective: Elevated serum uric acid (SUA) is increasingly recognized as a risk factor for kidney disease in adults with diabetes, but data in youth are limited. We hypothesized that elevated SUA predicts development of elevated urinary albumin excretion (UAE) and hypertension over time in teens with type 2 diabetes (T2D).

Research Design And Methods: Serum creatinine, cystatin C, SUA, and the urine albumin-to-creatinine ratio (UACR) were assessed in 539 obese youth, ages 12-17 years, with T2D duration <2 years at baseline in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.

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Objective: The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes.

Study Design: This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy.

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Importance: Administration of corticosteroids to women at high risk for delivery in the late preterm period (34-36 weeks' gestation) improves short-term neonatal outcomes. The cost implications of this intervention are not known.

Objective: To compare the cost-effectiveness of treatment with antenatal corticosteroids with no treatment for women at risk for late preterm delivery.

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Objective: To evaluate sex-specific genetic susceptibility to adverse neurodevelopmental outcome (ANO, defined as cerebral palsy [CP], mental, or psychomotor delay) at risk for early preterm birth (EPTB, < 32 weeks).

Study Design: Secondary case-control analysis of a trial of magnesium sulfate (MgSO) before anticipated EPTB for CP prevention. Cases are infants who died by the age of 1 year or developed ANO.

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Association of Gestational Diabetes Mellitus With Neonatal Respiratory Morbidity.

Obstet Gynecol

February 2019

Brown University, Providence, Rhode Island; Dartmouth College, Lebanon, New Hampshire; the George Washington University Biostatistics Center, Washington, DC; Columbia University, New York, New York; the University of Texas Health Science Center at Children's Memorial Hermann Hospital, Houston, Texas; the University of Alabama at Birmingham, Birmingham, Alabama; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; Emory University, Atlanta, Georgia; the University of Texas Medical Branch, Galveston, Texas; The Ohio State University, Columbus, Ohio; the University of Utah Health Sciences Center, Salt Lake City, Utah; the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio; Northwestern University, Chicago, Illinois; Duke University, Durham, North Carolina; Stanford University, Stanford, California; the University of Texas Southwestern Medical Center, Dallas, Texas; University of Pittsburgh, Pittsburgh, Pennsylvania; Oregon Health and Science University, Portland, Oregon; and Wayne State University, Detroit, Michigan.

Objective: To assess neonatal respiratory morbidity in pregnancies with and without gestational diabetes mellitus (GDM) at imminent risk of late preterm delivery in a modern U.S. cohort.

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Daytime Compared With Nighttime Differences in Management and Outcomes of Postpartum Hemorrhage.

Obstet Gynecol

January 2019

Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, the University of Utah Health Sciences Center, Salt Lake City, Utah, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, the University of Texas Southwestern Medical Center, Dallas, Texas, the University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, the University of Alabama at Birmingham, Birmingham, Alabama, the University of Texas Medical Branch, Galveston, Texas, Wayne State University, Detroit, Michigan, Brown University, Providence, Rhode Island, the University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas, and Oregon Health & Science University, Portland, Oregon; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To assess whether postpartum hemorrhage management or subsequent morbidity differs based on whether delivery occurred during the day or night.

Methods: We conducted a secondary analysis of a multicenter observational obstetric cohort of more than 115,000 mother-neonate pairs from 25 hospitals (2008-2011). This analysis included women delivering singleton or twin births who experienced postpartum hemorrhage (estimated blood loss greater than 500 cc for vaginal delivery, estimated blood loss greater than 1,000 cc for cesarean delivery, or documented treatment for postpartum hemorrhage).

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Purpose: To evaluate for differences in neurodevelopmental outcomes at 30 months of age for children enrolled in the Management of Myelomeningocele Study (MOMS) based on the presence of hydrocephalus and cerebral shunts.

Methods: Children with no hydrocephalus (N= 27), children with shunted hydrocephalus (N= 108), and children with unshunted hydrocephalus (N= 36) were compared at 30 months of age on the Bayley II Mental and Psychomotor Indices, the Peabody Developmental Motor Scales-2 and the Preschool Language Scale, 4th edition. Generalized linear models were used to adjust for factors significantly different between the groups at baseline.

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Objective: Obese youth without diabetes with monophasic oral glucose tolerance test (OGTT) glucose response curves have lower insulin sensitivity and impaired β-cell function compared with those with biphasic curves. The OGTT glucose response curve has not been studied in youth-onset type 2 diabetes. Here we test the hypothesis that the OGTT glucose response curve at randomization in youth in the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study forecasts heightened glycemic failure rates and accelerated decline in β-cell function.

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Association Between Gestational Weight Gain and Perinatal Outcomes.

Obstet Gynecol

October 2018

Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Texas Medical Branch, Galveston, Texas, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, Wayne State University, Detroit, Michigan, Brown University, Providence, Rhode Island, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, and Oregon Health & Science University, Portland, Oregon; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To evaluate the association between gestational weight gain and maternal and neonatal outcomes in a large, geographically diverse cohort.

Methods: Trained chart abstractors at 25 hospitals obtained maternal and neonatal data for all deliveries on randomly selected days over 3 years (2008-2011). Gestational weight gain was derived using weight at delivery minus prepregnancy or first-trimester weight and categorized as below, within, or above the Institute of Medicine (IOM) guidelines in this retrospective cohort study.

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Intrapartum Fetal Heart Rate Tracing Among Small-for-Gestational Age Compared With Appropriate-for-Gestational-Age Neonates.

Obstet Gynecol

October 2018

Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas; University of Texas Medical Branch, Galveston, Texas; University of Utah Health Sciences Center, Salt Lake City, Utah; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; University of Alabama at Birmingham, Birmingham, Alabama; Columbia University, New York, New York; Northwestern University, Chicago, Illinois; The Ohio State University, Columbus, Ohio; MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio; Brown University, Providence, Rhode Island; University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado; Stanford University, Stanford, California; Wayne State University, Detroit, Michigan; and University of Pittsburgh, Pittsburgh, Pennsylvania; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To compare fetal heart rate (FHR) patterns during the last hour of labor between small-for-gestational-age (SGA; birth weight less than the 10th percentile for gestational age) and appropriate-for-gestational-age (AGA; birth weight at the 10-90th percentile) neonates at 36 weeks of gestation or greater. We also compared the rate of cesarean delivery and composite neonatal morbidity among SGA and AGA newborns.

Methods: This is a secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis.

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Objective: To assess whether treatment of pregnant women with subclinical hypothyroidism or hypothyroxinemia alters neonatal TSH results.

Study Design: A planned secondary analysis of data from two multi-center randomized, double-masked, placebo-controlled thyroxine replacement trials in pregnant women with either subclinical hypothyroidism or hypothyroxinemia. Infant heel-stick specimens were obtained before discharge.

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Labor Induction versus Expectant Management in Low-Risk Nulliparous Women.

N Engl J Med

August 2018

From the Department of Obstetrics and Gynecology, Northwestern University, Chicago (W.A.G., G.M.); University of Alabama at Birmingham, Birmingham (A.T.N.T.); University of Utah Health Sciences Center, Salt Lake City (R.M.S., K.H.); Stanford University, Stanford, CA (Y.Y.E.-S.); Columbia University, New York (A.P.-D.); Brown University, Providence, RI (D.J.R.); University of Texas Medical Branch, Galveston (G.R.S.), University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and University of Texas Southwestern Medical Center, Dallas (B.M.C.) - all in Texas; University of North Carolina at Chapel Hill, Chapel Hill (K.A.B.), and Duke University, Durham (G.K.S.) - both in North Carolina; Ohio State University, Columbus (J.D.I.), and MetroHealth Medical Center, Case Western Reserve University, Cleveland (E.K.C.) - both in Ohio; University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); University of Pennsylvania, Philadelphia (S.K.S.); University of Pittsburgh, Pittsburgh (H.N.S.) - both in Pennsylvania; Washington University, St. Louis (G.A.M.); the George Washington University Biostatistics Center, Washington, DC (M.M.R., E.A.T.); and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.).

Background: The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain.

Methods: In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days of gestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was cesarean delivery.

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To determine the association of maternal glycemia with childhood obesity and metabolic dysfunction. Secondary analysis of follow-up data 5-10 years after a mild gestational diabetes mellitus (GDM) treatment trial. The relationship between maternal oral glucose tolerance testing (OGTT) at 24-31-week gestation and body mass index (BMI), fasting glucose, insulin, and anthropometric measurements (sum of skinfolds, subscapular/triceps ratio, and waist circumference) in the offspring of untreated mild GDM and non-GDM (abnormal 50-g screen/normal OGTT) women was assessed.

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Aims: We aimed to determine the prevalence of arterial stiffness in young adults with youth-onset type 2 diabetes who previously participated in the TODAY clinical trial and whether arterial stiffness is influenced by their prior diabetes treatment assignment or glycemic control.

Methods: We measured arterial stiffness by femoral, radial, and foot pulse wave velocity (PWV), augmentation index (AIx), and brachial distensibility (BrachD) in 453 TODAY participants (age 20.8 ± 2.

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Importance: Urinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage.

Objective: To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.

Design, Setting, And Participants: We conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase).

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Background: Studies of early-term birth after demonstrated fetal lung maturity show that respiratory and other outcomes are worse with early-term birth (37-38 weeks) even after demonstrated fetal lung maturity when compared with full-term birth (39-40 weeks). However, these studies included medically indicated births and are therefore potentially limited by confounding by the indication for delivery. Thus, the increase in adverse outcomes might be due to the indication for early-term birth rather than the early-term birth itself.

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Objective To determine the frequency of sepsis and other adverse neonatal outcomes in women with a clinical diagnosis of chorioamnionitis. Methods We performed a secondary analysis of a multi-center placebo-controlled trial of vitamins C/E to prevent preeclampsia in low risk nulliparous women. Clinical chorioamnionitis was defined as either the "clinical diagnosis" of chorioamnionitis or antibiotic administration during labor because of an elevated temperature or uterine tenderness in the absence of another cause.

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Objective: To estimate the magnitude of the correlation between neonatal outcomes of twins and demonstrate how this information can be used in the design of randomised controlled trials (RCTs) in women with twin pregnancies.

Design: Secondary analysis of data from 12 RCTs.

Setting: Obstetric care in multiple countries, 2004-2012.

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Variation in the Nulliparous, Term, Singleton, Vertex Cesarean Delivery Rate.

Obstet Gynecol

June 2018

Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; Northwestern University, Chicago, Illinois; MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio; Columbia University, New York, New York; the University of Utah Health Sciences Center, Salt Lake City, Utah; the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; the University of Texas Southwestern Medical Center, Dallas, Texas; the University of Pittsburgh, Pittsburgh, Pennsylvania; The Ohio State University, Columbus, Ohio; the University of Texas Medical Branch, Galveston, Texas; Wayne State University, Detroit, Michigan; Brown University, Providence, Rhode Island; the University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas; Oregon Health & Science University, Portland, Oregon; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To estimate the contributions of patient and health care provider-hospital characteristics to the variation in the frequency of nulliparous, term, singleton, vertex cesarean delivery in a multi-institutional U.S. cohort.

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